Cytel and AstraZeneca Early Clinical Development Software
Collaboration Facilitates Clinical Development Decision-Making

November 29, 2016 07:50 AM Eastern Standard Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cytel Inc., a provider of software and clinical research services to the
biopharmaceutical industry today announced the successful implementation
of a software interface for go/no-go decision-making within its client
AstraZeneca. The software is the result of extensive collaborative work
by the two organizations and marks a significant advancement in
quantitative decision-making capabilities for the biopharmaceutical
industry.

Since 2014 AstraZeneca has operated a quantitative standard
decision-making framework across its Early Clinical Development (ECD)
group. Based on a statistical method initially proposed by Lalonde et al
(1) and extended by AstraZeneca ECD Biometrics (Frewer et al (2)) to
include Bayesian as well as frequentist assessments, the approach
ensures that studies are designed from the outset with the decision in
mind. Once results are available they can then be interpreted against
pre-determined criteria, allowing clear decisions to be made faster, and
supporting the management of risk across the clinical portfolio. This
also provides a quantitative framework for interim assessment of
futility and efficacy. The goal is to ensure effective compounds may be
accelerated through the development process, while ineffective ones are
terminated early. To support robust go/no-go decisions, every early
phase trial within the group must produce decision criteria as part of
the governance review.

Cytel has collaborated with AstraZeneca to enhance the efficiency of the
established process by developing a user-friendly interface which
simplifies the creation of decision information and reduces programming
time. James Matcham, Head of ECD Biometrics at AstraZeneca, said, “The
software collaboration with Cytel has added value to our decision-making
approach. The creation of consistent, presentation quality decision
plots eases communication between stakeholders. With this software tool
in place decision information can now be generated in real-time. As well
as saving time for the statisticians and the clinical project team,
improving decision-making will help us to develop the right medicines
for areas of high unmet medical need, and get these medicines to
patients more quickly.”

Vice President Consulting and Software, Yannis Jemiai of Cytel said, “We
are passionate about using statistical expertise to help our clients
make better decisions, faster. We believe that this kind of go/no-go
framework has the potential to positively impact clinical trial success,
and we are delighted to have created software that supports its
implementation.”

The software is a web-based platform using a Windows based server for
statistical computations and frequentist and Bayesian based approaches
may be accommodated. Biopharmaceutical companies interested in
developing a software interface to underpin their own decision-making
frameworks may contact Cytel via the details below.